Who is exempt from FDA registration?

Food Facility Registration The registration requirement applies to any facility that conducts these activities, unless a facility is specifically exempt under 21 CFR 1.226. For example, farms, retail food establishments, and restaurants are exempt from food facility registration requirements.

What is 415 a of the FD&C Act?

Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances.

Do warehouses need to register with FDA?

How to register your warehouse with the FDA. In order to become an FDA-certified warehouse, you must register your facilities with the FDA. By registering with the FDA, you agree to be inspected every three years. As long as you pass your inspections, your warehouse is considered to be approved by the FDA.

Should you give out your FDA registration number?

Unlike medical device and drug facilities, FDA Food Facility Registration data is not publicly available. FDA does not provide certification to registered food facilities and food facility registrations are not subject to under the Freedom of Information Act (21 CFR 1.243).

Who needs to register with the FDA food?

Food. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

Get Form Approval Omb 0910 0502

Q: What is 415 a of the FD&amp;C Act?

Section 415 of the FD&amp;C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances.

Form Approval OMB No. 0910-0502 Expiration Date 10/31/2006 See OMB Statement at end of form FDA USE ONLY USE BLUE OR BLACK INK ONLY DHHS/FDA CANCELLATION OF FOOD FACILITY REGISTRATION FORM PIN FACILITY REGISTRATION NUMBER O DOMESTIC REGISTRATION FOREIGN REGISTRATION FACILITY NAME / ADDRESS INFORMATION FACILITY STREET ADDRESS Line 1 CITY STATE ZIP CODE POSTAL CODE PROVINCE/TERRITORY COUNTRY CERTIFICATION STATEMENT The owner operator or agent in charge of the facility or an individual authorized by the owner operator or agent in charge of the facility must submit this form. By submitting this form to FDA or by authorizing an individual to submit this form to FDA the owner operator or agent in charge of the facility certifies that the above information is true and accurate. An individual other than the owner operator or agent in charge of the facility who submits the form to the FDA also certifies that the above information submitted is true and accurate and that he/she is authorized to submit the cancellation on the facility s behalf* An individual authorized by the owner operator or agent in charge must below identify by name the individual who authorized submission of the cancellation* Under 18 U*S*C. 1001 anyone who makes a materially false fictitious or fraudulent statement to the U*S* Government is subject to criminal penalties. SIGNATURE OF SUBMITTER PRINT NAME OF THE SUBMITTER CHECK ONE BOX O A. OWNER OPERATOR OR AGENT IN CHARGE STOP HERE FORM IS COMPLETED O B. INDIVIDUAL AUTHORIZED TO SUBMIT THE CANCELLATION FILL IN BELOW IF YOU CHECKED BOX B ABOVE INDICATE WHO AUTHORIZED YOU TO SUBMIT THE CANCELLATION O NAME OF INDIVIDUAL WHO AUTHORIZED CANCELLATION ON BEHALF OF OWNER OPERATOR OR AGENT IN CHARGE FILL IN BELOW ADDRESS INFORMATION FOR THE AUTHORIZING INDIVIDUAL AUTHORIZING INDIVIDUAL ADDRESS Line 1 PHONE NUMBER Include Area/Country Code DATE CANCELLATION FORM RECEIVED DATE CONFIRMATION SENT TO FACILITY MAIL COMPLETED FORM TO U*S* FOOD AND DRUG ADMINISTRATION HFS-681 5600 FISHERS LANE ROCKVILLE MD 20857 OR FAX IT TO 301 210-0247. Public reporting burden for this collection of information is estimated to average 1 hour per response including the time for reviewing instructions searching existing data sources gathering and maintaining the data needed and completing and reviewing the collection of information* Send comments regarding this burden estimate or any other aspect of this collection of information including suggestions for reducing this burden to Department of Health and Human Services An agency may not conduct or sponsor and a Food and Drug Administration person is not required to respond to a collection of CFSAN/PRB Comments HFS-024 information unless it displays a currently valid 5100 Paint Branch Parkway OMB control number. An individual other than the owner operator or agent in charge of the facility who submits the form to the FDA also certifies that the above information submitted is true and accurate and that he/she is authorized to submit the cancellation on the facility s behalf* An individual authorized by the owner operator or agent in charge must below identify by name the individual who authorized submission of the cancellation* Under 18 U*S*C. 1001 anyone who makes a materially false fictitious or fraudulent statement to the U*S* Government is subject to criminal penalties.

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